Seat No.: Enrolment
GUJARAT TECHNOLOGICAL UNIVERSITY
B.PHARM SEMESTER EXAMINATION -WINTER 2018
Subject Code:270001 Date: 15/11/2018
Subject Name: Dosage Form Design- I
Time:10:30 AM TO 01:30 PM Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make Suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q.1

Define polymorphism. Give the characteristics of polymorphisms.
06

Enumerate the chemical properties of drug for preformulation. Explain oxidation and its prevention in drug formulation.
05

Give the importance of particle size of drug in preformulation study.
05
Q.2

Define prodrug. Give the importance of prodrug in formulation.
06

Give the types of suspending agents used in suspension formulation.
05

Give the mechanisms and role of antioxidants in formulation.
05
Q.3

What is adjuvant? Give its importance in formulations. Give the FDA approved colors and their interaction in drug formulations.
06

What are overages? How do they calculate?
05

Write a note on accelerated stability testing for drug product.
05
Q.4

Explain the different types of climatic zone for drug stability.
06

How do the container and closure affect the drug stability?
05

Define half-life. Derive the equation for half-life for first order kinetic reaction.
05
Q.5

Give the difference between active transport and passive transport.
06

Explain volume of distribution of drug.
05

Explain the anatomy and physiology of cell membrane.
05
Q. 6

Enumerate the physiological factors for drug absorption and explain the gastric emptying time.
06

Define bioavailability. Explain the factors required to study the bioavailability.
05

Explain the BCS classification with suitable examples.
05
Q.7

Define bioequivalent. Explain the single dose bioequivalence study.
06

Explain the dissolution apparatus type I and type II as per USP.
05

Explain similarity and dissimilarity factors for drug dissolution.
05